MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, recently announced presentation of data from a Phase 1b/2a pilot study highlighting three patients who received pemziviptadil (PB1046), the company’s first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue for the treatment of pulmonary arterial hypertension (PAH).
The data, which were presented virtually at the 15th Pulmonary Vascular Research Institute (PVRI) World Congress on January 27, 2021, continue to highlight the favorable safety and tolerability profile of pemziviptadil, as well as clinically-meaningful, long-term improvement of six-minute walk test (6MWT) distance for one patient after eighteen months of treatment. Additionally, the data demonstrate stability in functional status with no clinically-meaningful deterioration for two patients at two and six months after treatment. Hemodynamic data from this same trial were presented at the 14th PVRI World Congress in early 2020.
The patients participated in PhaseBio’s Phase 1b/2a pilot study, which evaluated the multi-dose safety, pharmacokinetics (PK) and VIP-based pharmacodynamic effects of pemziviptadil in three PAH patients who have a permanently implanted hemodynamic monitor (CardioMEMS™ HF System), a device placed in the pulmonary artery that continuously measures heart rate along with systolic and diastolic pressures. Pemziviptadil was administered subcutaneously on a weekly basis for eight weeks (extended due to subjective improvements) at dose levels previously tested in Phase 1.
All three patients completed the study with no drug-related serious adverse events associated with study drug discontinuation and pemziviptadil appeared to be well tolerated. New efficacy data in this analysis included 6MWT distance, which improved (by +78 meters, 17% change from baseline) after 18 months of treatment in one patient, a 29-year-old, while showing no signs of clinically-meaningful deterioration in a 61 year old patient after two months of therapy (-9 meters, -2% change from baseline) or in a 74-year-old patient after 6 months of treatment (+16 meters, 7% change from baseline). In an ongoing 16-week randomized, double-blind, Phase 2b clinical trial of pemziviptadil in PAH patients (the VIP trial), PhaseBio is measuring pulmonary vascular resistance and 6MWT distance among other key efficacy endpoints in approximately 60 patients.
“Though these results are from a small number of patients in a pilot study of pemziviptadil, we are encouraged to see that this novel therapeutic agent has provided symptomatic relief and meaningful clinical benefits while continuing to demonstrate a favorable safety and tolerability profile,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio Pharmaceuticals. “Having observed early signs of potential efficacy in PAH patients with once-weekly pemziviptadil in this pilot study, we continue to be optimistic about the program and look forward to the results from the ongoing Phase 2b trial, which remains on track for a readout in the second half of this year.”
“The successful development of a once-weekly treatment with a potentially disease-modifying mechanism of action would be a major advancement for patients with PAH, which remains a major life-threatening condition with no cure,” added Dr. Raymond Benza, MD, FACC, Professor and Director, Division of Cardiovascular Medicine, the Ohio State University Wexner Medical Center, and National Principal Investigator for this trial.
A copy of the poster is available on the company’s website.
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